[18F]PI-2620 Phase 3 Histopathological Study

Last updated: January 6, 2026
Sponsor: Life Molecular Imaging Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

[18F]PI-2620

Clinical Study ID

NCT05641688
LMT-01-01-22
  • Ages > 50
  • All Genders

Study Summary

This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with [18F]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Only subjects who meet all of the following criteria will be eligible for enrollment into the study:

  1. Males and females aged 50 years and over

  2. Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limited to end-stage dementia,end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease (COPD), or end-stage cancer)

  3. Written informed consent obtained from the subject and/or the subject's legallyauthorized representative (LAR), as applicable, to consent for study procedures andbrain donation (consent consistent with the legal requirements of the State in whichthe subject dies)

  4. Can tolerate study procedures including lying down in PET scanner. The investigatorwill carefully assess each subject and use medical judgment to determine whether thesubject can tolerate the imaging procedure

Exclusion

Exclusion Criteria:

Subjects will be excluded from the enrollment if they:

  1. Are receiving aggressive treatment with life sustaining measures (e.g. receivingchemotherapy; palliative chemotherapy is allowed)

  2. Are known to have a structural brain lesion that would interfere either with PETimaging or pathological assessment (e.g. lesions are typically > 2 cm at theirgreatest extent and may include stroke, primary or metastatic neoplasm, other tumorsor cystic lesions. Subjects with a history of major stroke or traumatic brain injuryor other structural lesion as well as cases with a history of primary CentralNervous System (CNS) neoplasm or known metastatic cancer must be discussed with thestudy sponsor prior to enrollment)

  3. Have suspected encephalopathy due to alcoholism or end-stage liver disease

  4. Are known to have a Glomerular Filtration Rate below < 15 mL/min

  5. Have received an investigational or approved therapy directly targeting amyloid ortau

  6. Are females of childbearing potential who are pregnant, lactating or breastfeeding,or who are not using adequate contraception

  7. Have implants such as implanted cardiac pacemakers or defibrillators, insulin pumps,cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNSaneurysm clips and other medical implants that have not been certified for MRI, orhistory of claustrophobia in MRI (in case an MRI is planned to be performed)

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: [18F]PI-2620
Phase: 3
Study Start date:
December 01, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85352
    United States

    Site Not Available

  • Barrow Neurological Institute

    Phoenix 5308655, Arizona 5551752 85013
    United States

    Active - Recruiting

  • Banner Sun Health Research Institute

    Sun City 5316201, Arizona 5551752 85352
    United States

    Active - Recruiting

  • UC Los Angeles

    Los Angeles, California 90095 - 7370
    United States

    Site Not Available

  • Esperanza Clinical

    Murrieta, California 92562
    United States

    Site Not Available

  • Sutter Health

    San Francisco, California 94114
    United States

    Site Not Available

  • UC Los Angeles

    Los Angeles 5368361, California 5332921 90095 - 7370
    United States

    Active - Recruiting

  • Esperanza Clinical

    Murrieta 5375911, California 5332921 92562
    United States

    Active - Recruiting

  • Sutter Health

    San Francisco 5391959, California 5332921 94114
    United States

    Active - Recruiting

  • Galiz Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • UF College of Medicine - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • K2 Medical Research

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • ClinCloud Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Miami Jewish Health Systems

    Miami, Florida 33137
    United States

    Active - Recruiting

  • Verus Clinical Research

    Miami, Florida 33125
    United States

    Site Not Available

  • The Roskamp Institute

    Sarasota, Florida 34243
    United States

    Site Not Available

  • Charter Research

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Galiz Research

    Hialeah 4158476, Florida 4155751 33016
    United States

    Active - Recruiting

  • UF College of Medicine - Jacksonville

    Jacksonville 4160021, Florida 4155751 32209
    United States

    Active - Recruiting

  • K2 Medical Research

    Lady Lake 4161118, Florida 4155751 32159
    United States

    Active - Recruiting

  • ClinCloud Research

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • ClinCloud Research

    Melbourne 4163971, Florida 4155751 32940
    United States

    Active - Recruiting

  • Miami Jewish Health Systems

    Miami 4164138, Florida 4155751 33137
    United States

    Active - Recruiting

  • The Roskamp Institute

    Sarasota 4172131, Florida 4155751 34243
    United States

    Terminated

  • Charter Research

    Winter Park 4178560, Florida 4155751 32792
    United States

    Active - Recruiting

  • Alzheimer's Disease Center

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Headlands Research

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Alzheimer's Disease Center

    Braintree 7257540, Massachusetts 6254926 02184
    United States

    Active - Recruiting

  • Headlands Research

    Plymouth 4947597, Massachusetts 6254926 02360
    United States

    Active - Recruiting

  • Be Well Clinical Studies

    Lincoln, Nebraska 68616
    United States

    Site Not Available

  • Be Well Clinical Studies

    Lincoln 5072006, Nebraska 5073708 68616
    United States

    Active - Recruiting

  • Darthmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 07366
    United States

    Site Not Available

  • Darthmouth-Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 07366
    United States

    Active - Recruiting

  • Velocity Clinical Research

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Ichor Research

    Syracuse, New York 13219
    United States

    Site Not Available

  • Velocity Clinical Research

    East Syracuse 5116079, New York 5128638 13057
    United States

    Active - Recruiting

  • Ichor Research

    Syracuse 5140405, New York 5128638 13219
    United States

    Active - Recruiting

  • American Carolina Clinical Research LLC

    Charlotte, North Carolina 28273
    United States

    Site Not Available

  • American Carolina Clinical Research LLC

    Charlotte 4460243, North Carolina 4482348 28273
    United States

    Terminated

  • Insight Clinical Trials LLC

    Beachwood, Ohio 44131
    United States

    Site Not Available

  • Valley Medical Research

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Insight Clinical Trials LLC

    Beachwood 5146711, Ohio 5165418 44131
    United States

    Active - Recruiting

  • Valley Medical Research

    Centerville 4508204, Ohio 5165418 45459
    United States

    Active - Recruiting

  • Baylor Research Institute

    Dallas, Texas 75231
    United States

    Site Not Available

  • Sante Clinical Research

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Be Well Clinical Studies

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Baylor Research Institute

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Sante Clinical Research

    Kerrville 4703078, Texas 4736286 78028
    United States

    Active - Recruiting

  • Be Well Clinical Studies

    Round Rock 4724129, Texas 4736286 78681
    United States

    Active - Recruiting

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